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. 2017 Feb 3;2017(2):CD008312. doi: 10.1002/14651858.CD008312.pub3

Modi 2013.

Methods Study design: RCT
Method of randomisation: via a permuted block randomisation method with block size of 2.
Setting: a new‐onset seizure clinic at a pediatric children’s hospital in the USA.
Date it was conducted: not reported.
Follow up: 4 months.
Source of funding: National Institute of Health
Conflict of interest: the authors declare no conflict of interest.
Participants inclusion/exclusion criteria: diagnosis of a non epilepsy medical disorder requiring daily medication, a significant developmental disorder (e.g. autism), or the family living >90 miles away from the hospital. Families had to read/speak English.
Sample size: 40 families were approached for study participation; 30 agreed to participate and 3 withdrew before randomisation or did not return. After a 1‐month run‐in period, participants with near perfect adherence (> 90%) were monitored (n = 19). Participants with adherence < 90% (n = 8) were randomly assigned to IG or to the CG group.
Age: mean age was 8.0 years (SD 5.6) in the IG and 7.1 years (SD 2.3) in the CG.
Gender: 50% male
Other characteristics: mean duration since diagnosis was 3.2 months (SD 1.2) in the IG group and 1.5 months (SD 0.88) in the CG
Interventions Type of intervention: educational
The IG received 4 sessions over > 2 months. The first component of the intervention (session 1) provided education on epilepsy treatment, AED adherence and the family’s specific epilepsy treatment regimen (i.e. dosing schedule). Sessions 2 through 4 aimed to teach families a problem‐solving approach for their identified AED‐adherence barriers.
Outcomes Primary outcome(s) measured: adherence
It was measured by an electronic monitoring system that measures the time and date a pill bottle and cap were opened.
Secondary outcome(s) measured: assessment of feasibility and acceptability of the adherence Intervention.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Permuted block randomisation with block size of 2 was described
Allocation concealment (selection bias) Unclear risk No information on concealment was reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information on blinding was reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information on blinding was reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Missing outcome data balanced in numbers across groups with similar reasons for missing data
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Insufficient rationale or evidence that an identified problem will introduce bias